XXX产品回收工艺验证方案--模.pdf

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1、XXXX产品母液回收工艺验证方案ValidationProtocolonRecoveredMaterialsforXXXX起草(PreparedbyWorkshop):审核(ReviewedbyQA):审核(ReviewedbyQC):批准(ApprovedbyQAManager):编号�xxPVxxx-xxP第1页共9页验证目录TableofContents1、验证目的(ValidationPurpose)�....................................................................3

2、2、验证小组及职责(ValidationGroupandResponsibility)..................................33、.生产工艺简介(BriefDescriptionofProductionProcess)�.............................43.1母液回收套用工艺流程图(FlowChartofRecoveryofMotherLiquor)....43.2母液回收工艺描述(DescriptionofRecoveryProcess)..........................

3、...53.3回收物料套用工艺描述(DescriptionofReusedProcessforRecoveredMaterials)�.......................................................................................................53.4回收物料的储存周期(StorePeriodofRecoveredMaterials)....................55、验证过程(ValidationContents).............

4、...............................................................65.1、验证前提的确认......................................................................................65.2批号选择(ValidationBatchChoice)...........................................................65.3验证标准(AcceptanceCriter

5、ia)................................................................66、验证数据处理(Validationdatacollection)...........................................................76.1批号追踪(BatchTraceability)...................................................................76.2各工序数据汇总(DataColle

6、ctionofEachStage)�...................................76.2.1母液回收工序数据汇总(ProcessDataCollection)�..............................76.2.2XXXX工序数据汇总(DataCollectionofxxxxStage)�...........................86.2.3XXXX工序数据汇总(DataCollectionofxxxxStage)�...........................87、验证结论(Gen

7、eralConclusion):........................................................................98�验证进度表(ValidationSchedule).....................................................................9第2页共9页1、验证目的(ValidationPurpose)�根据cGMP和ICHQ7的要求�对于回收物料应加强过程控制和监控�确保回收物料符合设定的标准�并有足够的文件支持。【

8、XXXX产品的工艺简介�在YYYY工序存在回收物料的循环套用。】对于XXXX产品的母液回收系统�我们着重从三个方面进行控制。一是我们对母